Recruiting

Canary CTE

Sponsor:

Canary Medical

Code:

NCT05693818

Conditions

Arthritis Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Limping Evalution

Study Details

Brief summary:

The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.

Conditions

Arthritis Knee

Study ID

NCT05693818

Start date

Jan 31, 2023

Status verified date

Sep, 2023

Completion date

May 15, 2024

Anticipated

Primary completion date

May 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Patient must be 18 years of age or older

  • Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
  • Patient must be willing and able to complete the protocol required follow-up
  • Patient has participated in the study-related informed consent process
  • Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent

Exclusion Criteria:

  • • Simultaneous bilateral TKA

  • Staged bilateral TKA less than 6 months from indexed procedure
  • Patient is a current alcohol or drug abuser
  • Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
  • Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
  • Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
  • Patient with Neuropathic Arthropathy
  • Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
  • Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait

Study Design

Enrollment

88 participants

Anticipated

Interventions and Outcome Measures

Arms

PersonaIQ

Patients indicated for a PersonaIQ total knee arthroplasty

Interventions

Clinical Limping Evalution

Patients will be asked to perform a Clinical Limping Evaluation in the clinic during their post-operative follow-up visit. This will be performed in a controlled environment within the physician's clinic. Each patient will be asked to walk at their normal walking speed down a hallway for at least 7 consecutive steps and back toward the physician. Walking down the hallway and back is one walking trial. Each patient will be asked to perform 2 walking trials. The health care provider will assess the patient's limp using a 3-point Likert scale (0=No limp, 1=mild/moderate limp, 2=severe limp).

If required, patients may use an assistive device and the type of device should be documented. If a patient requires assistance, only the minimum amount of assistance required for a patient to complete the task should be provided.

Primary outcome measure

  • Limp Severity [ Time Frame: 4-6 wks+3 days weeks post TKA ]

Central Contacts and Locations

Central contacts

Derek E. Coulter

18066816979dcoulter@canarymedical.com

Nora York

nyork@canarymedical.com

Locations

Carolina Orthopaedic & Neurosurgical Associates

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Daniel Gerscovich, MD

864-582-6396

Principal Investigator:

Daniel Gerscovich, MD

More Information

Sponsor

Canary Medical

Last update posted

Sep 21, 2023

Last verified

Sep, 2023

Keywords

  • total knee arthroplasty
  • PersonaIQ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canary Medical on 2023-09-21.